Study of ALXN1840 on the Metabolism of a CYP2B6 Substrate in Healthy Participants
Study Identifier:
ALXN1840-HV-103
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete
Available Documents
Study Details
Medical Condition
- Unmapped
Study Drug
- Drug: ALXN1840
- Drug: Bupropion Hydrochloride
Date
Oct 2020 - May 2021
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 50 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- Adequate venous access in the left or right arm to allow the collection of blood samples.
- Body weight ≥ 45 to ≤ 100 kilograms (kg) and body mass index within the range of 18 to \< 30 kg/meter squared.
- Willing and able to follow protocol-specified contraception requirements.
- Capable of giving signed informed consent.
Exclusion Criteria
- History or presence of/significant medical history.
- Clinically significant multiple or severe allergies.
- Lymphoma, leukemia, or any malignancy within 5 years.
- Breast cancer within the past 10 years.
- Serum creatinine \> upper limit of normal (ULN) of the reference range.
- Alanine aminotransferase, aspartate aminotransferase, or total bilirubin \> ULN.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- QTc \> 450 milliseconds (msec) for male participants or \> 470 msec for female participants.
Sex
Female & Male
Age
18 - 50 Years
Study Details
Medical Condition
- Unmapped
Study Drug
- Drug: ALXN1840
- Drug: Bupropion Hydrochloride
Date
Oct 2020 - May 2021
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 50 Years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- Adequate venous access in the left or right arm to allow the collection of blood samples.
- Body weight ≥ 45 to ≤ 100 kilograms (kg) and body mass index within the range of 18 to \< 30 kg/meter squared.
- Willing and able to follow protocol-specified contraception requirements.
- Capable of giving signed informed consent.
Exclusion Criteria
- History or presence of/significant medical history.
- Clinically significant multiple or severe allergies.
- Lymphoma, leukemia, or any malignancy within 5 years.
- Breast cancer within the past 10 years.
- Serum creatinine \> upper limit of normal (ULN) of the reference range.
- Alanine aminotransferase, aspartate aminotransferase, or total bilirubin \> ULN.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- QTc \> 450 milliseconds (msec) for male participants or \> 470 msec for female participants.
Protocol Summary
This is a Phase 1, randomized, 2-period, 2-sequence, cross-over study designed to determine the effect of ALXN1840 on the metabolism of bupropion, a sensitive cytochrome P450 2B6 (CYP2B6) substrate, in healthy male and female participants. The safety and tolerability of ALXN1840 will be determined along with ALXN1840 pharmacokinetics (PK) in plasma as measured via total molybdenum with the coadministration of bupropion.
Trial Locations
Location
Status
Location
Clinical Trial Site
Austin, Texas, United States, 78744
Status
N/A